About
Periodic safety update report single assessments (PSUSAs) are single assessments of related periodic safety update reports (PSURs) for active substances contained in medicines authorised in the European Union (EU). A PSUR is a pharmacovigilance report submitted regularly by a marketing-authorisation holder at defined time points following a medicine's authorisation.
Key facts
- Active substance(s) in scope of the PSUSA procedure
- isotretinoin (oral formulations)
- Procedure number
- PSUSA/00010488/201905
- Regulatory outcome
- Variation
Documents
Isotretinoin (oral formulations): List of nationally authorised medicinal products - PSUSA/00010488/201905
English (EN) (376.77 KB - PDF)
Isotretinoin (oral formulations): CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010488/201905
English (EN) (33.27 KB - PDF)
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